LO-50 LED Light Source
FDA 510(k) K102167 · Fiberoptics Technology, Inc.
510(k) numberK102167
Submission
- Device name
- LO-50 LED Light Source
- Applicant
- Fiberoptics Technology, Inc.
Pomfret, CT, US - Received
- August 2, 2010
- Decision date
- August 17, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- NTN – Led Light Source
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals
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| K122831 | Video System CenterNTN · Traditional | Olympus Medical Systems Corp. | 12/14/2012SE |
| K113679 | Lucea LED Surgical Light SystemNTN · Special | Maquet S.A.S. | 01/12/2012SE |
| K103813 | Sopro 281NTN · Traditional | Sopro | 03/22/2011SE |
| K091829 | PLS Portable Light SourceNTN · Abbreviated | Optim, Inc. | 07/28/2009SE |
| K090601 | FSC 2NTN · Traditional | Schoelly Imaging, Inc. | 05/11/2009SE |
More from Schoelly Imaging, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K904378 | F.T.I. Medical Light GuideEQH · Traditional | 01/16/1991SE |
Questions and answers
When was LO-50 LED Light Source cleared by the FDA?
LO-50 LED Light Source (K102167) received a 510(k) decision of Substantially Equivalent on August 17, 2010, 15 days after the submission was received.
What is the product code of K102167?
The FDA product code is NTN – Led Light Source, a Class II (moderate risk) device regulated under 21 CFR 876.1500.